Introducer system with valve

Abstract

The present invention discloses an introducer system comprising an introducer sheath, a valve assembly, and a medical device passage. The valve assembly comprises a flexible material having an inner surface exposed along a portion of the medical device passage and an outer surface defining a valve membrane chamber. Furthermore, the compliance chamber within the valve assembly communicates with the valve membrane chamber and houses a piston assembly that is movable between positions to accommodate an expansion medium.

Description

Cross - Reference to Related Applications , ,

[0004]

[0001] This application claims the benefit and priority of U.S. Provisional Application No. 63 / 519,110, filed on August 11, 2023, entitled "Introducer System with an Inflatable Valve", the entire disclosure of which is incorporated herein by reference.

Background Art

[0002] Introducer sheaths are commonly used to introduce guidewires, catheters, and similar devices into a patient's vascular system. Valves are also typically used with introducer sheaths to maintain hemostasis and prevent excessive bleeding. Such hemostatic valves typically remain closed when no instrument is positioned within the introducer sheath and seal around the instrument when an instrument is positioned within the introducer sheath.

Summary of the Invention

[0003] In some aspects, the technology described herein relates to an introducer system, the system comprising an introducer sheath, a valve assembly connected to the introducer sheath, a medical device passage defined by the introducer sheath and the valve assembly, a flexible material within the valve assembly having an inner surface exposed along a portion of the medical device passage and an outer surface at least partially defining a valve membrane chamber, and a compliance chamber within the valve assembly and in communication with the valve membrane chamber, the compliance chamber further including a piston assembly movable between a plurality of positions within the compliance chamber for accommodating an inflation medium.

[0004] In some embodiments, the technology described herein relates to an introducer system, the piston assembly comprising a piston member connected to a piston seal and a biasing member, the biasing member biasing the piston member to reduce the working volume of the compliance chamber.

[0005] In some embodiments, the technology described herein relates to an introducer system, wherein the compliance chamber is arranged annularly around at least a portion of the valve diaphragm chamber.

[0006] In some embodiments, the technology described herein relates to an introducer system, wherein the piston member is a ring.

[0007] In some embodiments, the technology described herein relates to an introducer system, wherein the biasing member is a spring.

[0008] In some embodiments, the technology described herein relates to an introducer system, wherein the spring is a helical coil spring, a leaf spring, a disc spring, a flat plate spring, or a machined spring.

[0009] In some embodiments, the technology described herein relates to an introducer system, wherein the biasing member is an elastically compressible material, a pneumatic piston mechanism, or a hydraulic piston mechanism.

[0010] In some embodiments, the technology described herein relates to an introducer system, wherein the piston seal is a cup seal having an annular channel.

[0011] In some embodiments, the technology described herein relates to an introducer system, wherein the compliance chamber further includes an annular ridge positioned to engage with the annular channel of the cup seal.

[0012] In some embodiments, the technology described herein relates to an introducer system, wherein the flexible material generally has a tubular shape.

[0013] In some embodiments, the technology described herein relates to an introducer system, the generally tubular shape having a flexible middle section and radially enlarged ends.

[0014] In some embodiments, the technology described herein relates to an introducer system in which the flexible material forms a plurality of longitudinal pleats extending radially outward.

[0015] In some embodiments, the technology described herein relates to an introducer system, wherein the generally tubular shape further includes a slit valve covering the lumen of the generally tubular shape.

[0016] In some embodiments, the technology described herein relates to an introducer system further comprising a clamp connected to the valve assembly, the clamp having a closed clamp position configured to clamp the proximal portion of the dilator and an open clamp position configured to release the proximal portion of the dilator and allow the dilator to move longitudinally relative to the introducer sheath.

[0017] In some embodiments, the technology described herein relates to an introducer system, further comprising a pressure measuring device.

[0018] In some embodiments, the technology described herein relates to an introducer system, the valve assembly further includes a valve housing, at least a portion of which is transparent, and further includes markings indicating the pressure value of the expansion medium within the valve assembly.

[0019] In some embodiments, the technology described herein relates to an introducer system, wherein the piston member, the piston seal, or both are configured to align with the indicator to indicate the pressure value of the expansion medium in the valve assembly.

[0020] In some embodiments, the technology described herein relates to an introducer system, wherein the pressure measuring device comprises an electronic pressure transducer and an electronic display electrically connected to the pressure transducer.

[0021] In some embodiments, the technology described herein relates to an introducer system, wherein the compliance chamber further includes a plurality of compliance chambers.

[0022] In some embodiments, the technology described herein relates to an introducer system in which a plurality of compliance chambers are arranged in a ring around a medical device passage.

[0023] In some embodiments, the technology described herein relates to an introducer system, the system comprising an introducer sheath, a valve assembly connected to the introducer sheath, a medical device passage defined by the introducer sheath and the valve assembly, a valve member having an expansion configuration for sealing the medical device passage within the valve assembly, and a piston assembly located within the valve assembly and communicating with the valve member.

[0024] In some embodiments, the technology described herein relates to an introducer system, wherein the piston assembly is arranged in a ring around the medical device passage.

[0025] In some aspects, the technology described herein relates to an introducer system, the system comprising a valve assembly connected to an introducer sheath, a medical device passage defined by the valve assembly, a valve member having an inflation configuration for sealing the medical device passage within the valve assembly, and a piston assembly within the valve assembly and in communication with the valve member.

[0026] In some aspects, the technology described herein relates to an introducer system, and further comprises an introducer sheath connected to the valve assembly and further defining the medical device passage.

[0027] In some aspects, the technology described herein relates to an introducer system, the system comprising an introducer sheath, a valve assembly connected to the introducer sheath, a medical device passage defined by the introducer sheath and the valve assembly, and a pressure measurement mechanism configured to transmit pressure within the valve assembly.

[0028] <l In some aspects, the technology described herein relates to an introducer system, the pressure measurement mechanism including a transparent portion of the housing of the valve assembly, the pressure measurement mechanism being configured to measure an inflation medium within the valve assembly.

[0029] In some aspects, the technology described herein relates to an introducer system, and further comprises a marker located on the housing of the valve assembly, the marker being configured to indicate the pressure of the inflation medium within the valve assembly based on the position of components within a compliance chamber of the valve assembly.

[0030] In some aspects, the technology described herein relates to an introducer system, and the pressure measurement mechanism includes an electronic pressure transducer connected to an electronic display configured to display a pressure value measured from the electronic pressure transducer.

[0031] In some aspects, the technology described herein relates to a method of using an introducer system, the method comprising providing an introducer system including an introducer sheath and a valve assembly, the introducer sheath and the valve assembly defining a medical device passageway; filling the valve assembly with an inflation medium until a flexible material expands into and closes the medical device passageway; disposing a medical device within the medical device passageway; and accommodating displaced inflation medium due to movement of the flexible material by the medical device through a compliance chamber within the valve assembly, the compliance chamber including a piston assembly.

[0032] In some aspects, the technology described herein relates to an introducer system, the system comprising an introducer sheath, a valve assembly connected to the introducer sheath, a medical device passageway defined by the introducer sheath and the valve assembly, and a dilator, the dilator including a distal region having an annular channel, the introducer sheath including a distal end that decreases in diameter distally to fit within the annular channel of the dilator, minimizing a transition between an outer surface of the dilator and an outer surface of the introducer sheath.

[0033] In some embodiments, the technology described herein relates to an introducer system comprising an introducer sheath, a valve assembly connected to the introducer sheath, a medical device passage defined by the introducer sheath and the valve assembly, and a dilator, the dilator including a distal region having an annular channel, the introducer sheath including a distal end whose diameter decreases distally so as to fit within the annular channel of the dilator, and minimizing the transition between the outer surface of the dilator and the outer surface of the introducer sheath. 31. An introducer system comprising: an introducer sheath; a valve assembly connected to the introducer sheath; a medical device passage defined by the introducer sheath and the valve assembly; a dilator having a distal region having an annular channel, wherein the introducer sheath includes a distal end whose diameter decreases distally so as to fit within the annular channel of the dilator, minimizing the transition between the outer surface of the dilator and the outer surface of the introducer sheath; and a clamp assembly having an open state that allows longitudinal movement of the dilator relative to the valve assembly and the introducer sheath, and a clamp state that prevents longitudinal movement of the dilator relative to the valve assembly and the introducer sheath.

[0034] In some embodiments, the technology described herein relates to the introducer system described in 31, wherein the clamp assembly can be attached to the proximal portion of the valve assembly via an interlock mechanism.

[0035] In some embodiments, the techniques described herein relate to methods of using an introducer system, the method of providing an introducer system comprising an introducer sheath and a valve assembly, wherein the introducer sheath and the valve assembly define a medical device passage; the method of inserting a dilator into the valve assembly and the introducer sheath; adjusting the longitudinal position of the dilator so that a channel on the distal portion of the dilator aligns with the distal end of the introducer sheath; and clamping the proximal portion of the dilator to the valve assembly to prevent longitudinal movement of the dilator relative to the valve assembly and the introducer sheath.

[0036] In some embodiments, the techniques described herein relate to the method described in 33, wherein the step of inserting the dilator into the valve assembly further includes connecting the interlock assembly of the clamp assembly located on the proximal portion of the dilator to the valve assembly.

[0037] In some embodiments, the technology described herein relates to an introducer system comprising an introducer sheath, a valve assembly connected to the introducer sheath, a medical device passage defined by the introducer sheath and the valve assembly, and a dilator including a distal region having an annular channel, wherein the introducer sheath includes a distal end whose diameter decreases distally so as to fit within the annular channel of the dilator, minimizing the transition between the outer surface of the dilator and the outer surface of the introducer sheath, and further comprising a sheath moving assembly including an actuator for moving the introducer sheath longitudinally relative to the valve assembly and the dilator, the sheath moving assembly enabling a user to align the annular channel with the distal end of the introducer sheath.

[0038] In some embodiments, the technology described herein relates to the introducer system described in 35, wherein the actuator includes a thumbwheel, a slider, or a tubular actuator.

[0039] In some embodiments, the techniques described herein relate to methods of using an introducer system, the method of providing an introducer system comprising an introducer sheath and a valve assembly, wherein the introducer sheath and the valve assembly define a medical device passage; the method of inserting a dilator into the valve assembly and the introducer sheath; and adjusting the longitudinal position of the introducer sheath to align a channel on the distal portion of the dilator with the distal end of the introducer sheath.

[0040] In some embodiments, the techniques described herein relate to the method described in 37, wherein the step of inserting the dilator into the valve assembly further includes connecting the dilator interlock assembly on the proximal portion of the dilator to the valve assembly. [Brief explanation of the drawing]

[0041] The following drawings are included to illustrate specific exemplary aspects of the Disclosure and should not be considered exclusive or limiting. The disclosed subject matter may accept substantial modifications, alterations, combinations and equivalents in form and function, as will be apparent to those skilled in the art who are interested in the Disclosure. The Disclosure refers to the drawings as follows:

[0042] [Figure 1] Figure 1 shows side views of several examples of introducer systems 100.

[0043] [Figure 2]Figure 2 shows perspective views of the introducer system 100 of Figure 1 in relation to several examples.

[0044] [Figure 3] Figure 3 shows an enlarged side view of a valve assembly 102 relating to several examples.

[0045] [Figure 4] Figure 4 shows a perspective end view of the valve assembly 102 of Figure 3, relating to several examples.

[0046] [Figure 5] Figure 5 shows cross-sectional views of valve assemblies 102 in several examples.

[0047] [Figure 6] Figure 6 shows cross-sectional views of valve assemblies 102 in several examples.

[0048] [Figure 7] Figure 7 shows cross-sectional views of valve assemblies 102 in several examples.

[0049] [Figure 8] Figure 8 shows cross-sectional views of valve assemblies 102 in several examples.

[0050] [Figure 9] Figure 9 shows an enlarged cross-sectional view of a portion of a valve assembly 102, relating to several examples.

[0051] [Figure 10] Figure 10 shows a side view of the expanded valve diaphragm 128 in several examples.

[0052] [Figure 11] Figure 11 shows perspective views of the expanded valve diaphragm 128 in several examples.

[0053] [Figure 12]Figure 12 shows an end view of the expanded valve diaphragm 128 in several examples.

[0054] [Figure 13] Figure 13 shows side views of the valve membrane 128 in a contracted state in several examples.

[0055] [Figure 14] Figure 14 shows perspective views of spacer 136 in several examples.

[0056] [Figure 15] Figure 15 shows perspective views of a piston member 122 and a piston seal 120 in several examples.

[0057] [Figure 16] Figure 16 shows cross-sectional views of a piston member 122 and a piston seal 120 in several examples.

[0058] [Figure 17] Figure 17 shows side views of a piston member 122 and a piston seal 120 according to several examples.

[0059] [Figure 18] Figure 18 shows a side perspective view of a valve assembly 102 with an outer housing 112 having a transparent portion 112A, relating to several examples.

[0060] [Figure 19] Figure 19 shows enlarged cross-sectional views of the dilator 106 and introducer sheath 104 in several examples.

[0061] [Figure 20] Figure 20 shows an enlarged portion of area 20 in Figure 19, relating to several examples.

[0062] [Figure 21] Figure 21 shows perspective views of valve housings 160 in several examples.

[0063] [Figure 22] Figure 22 shows a cross-sectional view of a valve housing 160 with multiple compliance chambers 162 arranged at various annular positions around a medical device passage, relating to several examples.

[0064] [Figure 23] Figure 23 shows a side view of the introducer system 180 in which a thumbwheel moves the introducer sheath 104 relative to the dilator 106. [Modes for carrying out the invention]

[0065] Those skilled in the art will understand that this disclosure is not limited to what is specifically shown and described herein. In view of the teachings herein, various modifications and variations are possible without departing from their scope, spirit or intent.

[0066] While different examples may be described herein, it is particularly intended that any combination of features from different examples may be used and combined. In other words, features from different examples may be mixed and harmonized with each other. Accordingly, while not all permutations of features from different examples are explicitly shown or described, it is the intent of this disclosure to cover such combinations, particularly as can be understood by those skilled in the art.

[0067] Terms used in this disclosure should be interpreted in an acceptable manner and are not intended to be restrictive. In the drawings, similar numbers refer to similar elements. Unless otherwise stated, not all attached drawings are to scale. Unless otherwise stated, the term “approximately” is defined as plus or minus 5% of the stated value.

[0068] The terms distal or distal direction generally refer to the direction or region toward the end of the device within the patient (e.g., away from the physician / clinician), while the terms proximal or proximal direction refer to the direction or region toward the end of the device that remains outside the patient (e.g., toward or near the physician / clinician or the device's handle / hub).

[0069] This specification generally relates to introducer systems. Some examples herein relate to introducer sheaths, valve assemblies connected to the introducer sheaths, and passages defined by both components through which medical devices can pass. The valve assembly may include a flexible, expandable valve membrane that expands radially inward within the passage of the valve assembly to limit blood leakage during use and maintain hemostasis in a patient. When a medical device, such as a dilator, guidewire, catheter, or other medical device, is advanced through the passage of the valve assembly, the valve membrane maintains pressure against the medical device to maintain a seal.

[0070] The valve assembly may also include a compliance chamber communicating with the valve membrane chamber formed by the valve membrane. The compliance chamber helps to accommodate (e.g., receive and push out) various amounts of expansion medium required within the valve membrane chamber in order to maintain the valve membrane closed when the medical device passage is empty, or to seal around it when a medical device is present. When a medical device enters the passage and moves the valve membrane radially outward, the medium that expands the valve membrane and the valve membrane chamber is displaced into the medium compliance chamber, and the compliance chamber increases in size to accommodate the displaced medium. When the medical device is removed, the medium compliance chamber helps to expand the valve membrane so that it decreases in size and closes the passage. Thus, the inflatable valve membrane can automatically seal around medical devices of various different sizes, and when no device is present in the passage.

[0071] In some examples, the compliance chamber may include a piston member that moves axially back and forth to change the working volume of the compliance chamber. When the piston member moves toward the first end of the compliance chamber, the working volume of the chamber (i.e., the area of ​​the compliance chamber containing the expansion medium) increases, and a larger amount of expansion medium can be accommodated. When the piston member moves toward the second end of the compliance chamber, the working volume of the chamber decreases, and a smaller amount of expansion medium can be accommodated. The piston member may be biased toward the second end to help maintain the valve diaphragm in an expanded state, either toward itself or toward a medical device, if one is present.

[0072] In some examples, the introducer system may also include a dilator having a distal end with a conical taper that increases proximal, and a length such that the taper may extend from the distal end of the introducer sheath. Both the dilator and the introducer sheath are characterized by a more progressive radial transition between them (i.e., fewer abrupt "steps" in the transition between them). In one example, the dilator may include a groove or channel extending circumferentially around the dilator. The distal end portion of the introducer sheath may have a diameter that tapers distally both internally and externally. The taper of the introducer sheath may coincide with the taper of the groove / channel of the dilator, thereby allowing at least the most distal end of the introducer sheath to have approximately the same diameter as the portion of the dilator immediately distal to the groove / channel.

[0073] Figure 1 shows a side view of one specific example of the introducer system 100, and Figure 2 shows perspective views of the introducer system 100 relating to several examples. The introducer system 100 may include an introducer sheath 104 connected at its proximal end to a valve assembly 102 configured to maintain hemostasis when the distal portion of the introducer sheath 104 is located inside the patient.

[0074] As will be described in more detail below, the introducer sheath 104 and the valve assembly 102 each have lumens extending between their proximal and distal ends, and together they form a unified medical device passage into which the dilator and other medical devices can advance. In other words, the valve assembly 102 includes lumens that open at its proximal and distal ends, and the introducer sheath 104 also includes lumens that open at its proximal and distal ends, and together these lumens form a single unified medical device passage. Before placing the dilator 106 and the introducer sheath 104 into the patient's vascular structure, the physician may fill or fill the valve assembly 102 with an expanding medium to limit blood leakage from the patient and maintain hemostasis.

[0075] In some examples, the valve assembly 102 may be filled by injecting an expansion medium (e.g., a fluid) into an expansion passage 110. The expansion passage may include an expansion tube 110A that opens into the valve assembly 102 at one end and is attached to a valve 110B (e.g., a stopcock) at the other end of the expansion tube 110A. The valve 110B may include a port to which a syringe or similar device may be connected. After the expansion medium has been injected or filled into the valve assembly 102, the valve 110B may be closed.

[0076] In some examples, the valve assembly 102 may also have a flush passage 108 into which saline solution or another liquid can be flushed into the passage of the introducer system 100 to remove air. The flush passage 108 may include a flush tube 108A that opens at its first end into the lumen of the internal medical device of the valve assembly 102 and connects at its second end to a valve 108B (e.g., a stopcock valve). Thus, while the valve of the valve assembly 102 is closed, saline solution or another liquid can be added to the passage to help push out air bubbles.

[0077] The introducer system 100 may further include a dilator 106 having a conical tip 106A used to position at least the distal portion of the introducer sheath 104 within the patient. After at least the distal portion of the introducer sheath 104 is positioned within the patient's vascular structure, the dilator 106 can be removed from the introducer sheath 104 and the valve assembly 102.

[0078] As discussed elsewhere in this specification, the introducer system 100 may include certain features of the introducer sheath 104 and dilator 106 that help minimize the size of the transition between the outer surfaces of the two components, thereby reducing the possibility of the introducer sheath 104 getting caught on certain features when it enters the patient (e.g., a channel on the dilator 106 and the tapered distal tip of the introducer sheath 104). Because these features of the introducer sheath 104 and dilator 106 are relatively small in both their longitudinal length and their radial dimensions, it may be difficult to reliably manufacture these components with the tolerances required for reliable alignment. Therefore, the introducer system 100 may include a longitudinal alignment mechanism that allows the user to align the features of both components to the desired position to minimize the diametrical transition.

[0079] In one example, the longitudinal alignment mechanism may include a clamping mechanism that locks the dilator 106 in a predetermined longitudinal position relative to both the valve assembly 102 and the introducer sheath 104. In one example, the clamping mechanism may include a cam clamping mechanism that engages or disengages via a clamping lever 116 attached to the proximal end 114. However, other known clamping mechanisms are also possible. The clamping mechanism thus allows the user to further adjust the longitudinal position of the feature as needed to achieve a minimized or stepless transition. In one example, the clamping mechanism may be releasably connected to the proximal end of the valve assembly 102 via an interlocking assembly (e.g., tabs / grooves, clips, mating features, etc.) so that the dilator can be attached and removed as needed. The clamping assembly may initially be positioned on the proximal portion of the dilator 106 (e.g., non-removable or removable). In other examples, the clamping assembly may be non-removably fixed to the valve assembly 102.

[0080] Alternatively, the introducer system may include a mechanism that allows the sheath 104 to move relative to the dilator 106 and the valve assembly 102 to which it is attached. For example, Figure 23 shows an introducer system 180 that is substantially similar to the introducer system 100, except that instead of a clamping mechanism, the valve assembly 102 may include a mechanism that moves the introducer sheath 104 longitudinally. In this example, the thumbwheel 182 may engage with a toothed rack connected to the introducer sheath 104. However, other mechanisms are also possible, such as a thumb slider or an external tubular adjuster that rotates via a screw mechanism. In such an example, the proximal portion 106E of the dilator 106 may include an interlock mechanism that engages with the proximal end of the valve assembly 102.

[0081] Figure 3 shows an enlarged side view of the valve assembly 102, and Figure 4 shows a perspective end view of the valve assembly 102. Figures 5-9 show various cross-sectional views of the valve assembly 102. All of these drawings will be discussed together below.

[0082] The outer housing 112 can form a shell that accommodates many of the components of the valve assembly 102. In this example, the outer housing 112 is generally cylindrical, but it can also be non-cylindrical (e.g., rectangular).

[0083] In some examples, the valve mechanism of the valve assembly 102 may consist of at least two main components: a valve diaphragm 128 that expands radially inward within the internal passage of the valve assembly 102, and a compliance chamber 130 that dynamically accommodates the medium displaced by the movement of the valve diaphragm 128.

[0084] Figures 10-12 show various diagrams of an example of the valve membrane 128 in an expanded state, and Figure 13 shows the valve membrane 128 in a contracted state. The valve membrane 128 may have a generally tubular shape having an expanded end 128B and a flexible intermediate portion 128A that can be mounted within the outer housing 112. A passage may extend longitudinally through the valve membrane 128, and one or both ends of the passage may optionally have a slit valve 128C or a similar type of valve mechanism.

[0085] In the "expansion" state shown in Figures 10-12, the expansion medium (e.g., fluid) presses against the outer surface of the flexible intermediate portion 128A, causing it to compress or expand radially within its passage. If no medical device such as a dilator 106 or catheter is located through the passage of the valve membrane 128, the inner surfaces of the flexible intermediate portions 128A come into contact with each other, sealing the passage from blood. If one or more medical devices are located through the passage of the valve membrane 128, the flexible intermediate portions 128A come into contact with the outer surfaces of the one or more medical devices, sealing around them.

[0086] In the "contracted" state shown in Figure 13, the expansion medium does not press against the outer surface of the flexible intermediate portion 128A with little or no pressure, and the passage of the valve diaphragm 128 may be partially or completely open. The state shown in Figure 13 is most likely to occur during the initial stages of use of the introducer system 100, when the user can remove air from the valve assembly 102 before adding the expansion medium (e.g., fluid) through the expansion passage 110. Thus, in such a "contracted" state, the flexible intermediate portion 128A may have its maximum outer radial diameter, but otherwise it may not be expanded with the expansion medium with little or no pressure (i.e., the valve diaphragm chamber 140 may not be expanded with little / no pressure).

[0087] The valve membrane 128 may be composed of non-compliant / inelastic or partially non-compliant / inelastic materials, such as ePTFE, FEP, PFA, or FKM. In other examples, braided or woven fabric tubes coated to be impermeable to fluids and gases may also be used. In some examples, the valve membrane 128 may have a thickness within an inclusive range of about 20 to about 70 microns. Thus, in the “inflated” state in Figures 10 and 11, the flexible intermediate portion 128A is shown in this example having longitudinal pleats extending radially outward. However, the flexible intermediate portion 128A may form other shapes in the “inflated” state. The flexible intermediate portion 128A may have a circular cross-sectional shape, an elliptical cross-sectional shape, an hourglass shape with a smaller diameter near the center, an inverted hourglass shape with a larger diameter near the center, a linear taper in either the proximal or distal direction, or similar deformations.

[0088] The flexible intermediate portion 128A in this example is generally tubular in shape, but other shapes and configurations are possible. For example, the valve membrane 128 may instead include a plurality of individual membranes arranged in radial / circumferential positions similar to the flexible intermediate portion 128A in Figures 10 and 11. Alternatively, the valve membrane 128 may instead consist of a plurality of flexible tubes, each forming a balloon-like compartment that may also be arranged in radial / circumferential positions.

[0089] As described above, the valve assembly 102 may be filled or populated with a liquid expansion medium. Because liquids tend to be relatively incompressible, when a medical device is placed through the expanded flexible intermediate portion 128A, some of the expansion medium is displaced. The compliance chamber 130 provides space for such expansion medium by providing a dynamic working volume 130A that accepts the expansion medium as needed (e.g., when a medical device is inserted) and pushes out the expansion medium to maintain compliance of the flexible intermediate portion 128A or a desired level of expansion (e.g., when a medical device is removed from the flexible intermediate portion 128A). The working volume 130A is generally defined as the volume of the compliance chamber 130 that contains or is sized to contain the expansion medium at any given time, and the volume may change dynamically.

[0090] The compliance chamber 130 can take on various different shapes and positions within the valve assembly 102. In some examples, such as those in Figures 5-9, the compliance chamber 130 may be generally cylindrical with an annular or ring-shaped cross-section, and as a result, the compliance chamber 130 is positioned around the passage and the valve membrane 128. The annular cross-section refers to a cross-section taken generally perpendicular to the axis extending longitudinally through the lumen of the medical device in the valve assembly 102. The compliance chamber 130 may extend continuously around the periphery with a ring-shaped cross-section (e.g., an "O" shape), or it may extend only partially around the periphery cross-section (e.g., a "C" shape). In this example, the compliance chamber 130 is at least partially formed by the inner surface of the outer housing 112 and the inner tube 134.

[0091] In other examples, the compliance chamber 130 may instead comprise a plurality of separate chambers. For example, Figure 21 shows a perspective view, and Figure 22 shows a cross-sectional view of a valve housing 160 with a plurality of compliance chambers 162 arranged in various annular positions around a medical device passage, similar to a revolver. Each of these plurality of compliance chambers 162 may generally function similarly to the annular compliance chamber 130, but has a circular cross-sectional shape that forms a cylinder.

[0092] The compliance chamber 130 can dynamically change its operating volume 130A through several different mechanisms. For example, the compliance chamber 130 may include a biasing piston mechanism or piston assembly, an elastic membrane that can be deformed under pressure, one or more elastic balloons that can be expanded under pressure, or a similar mechanism.

[0093] In the examples shown in Figures 5-9, the compliance chamber 130 may include a piston mechanism comprising a piston member 122, a piston seal 120, and a spring 126. The piston member 122 and the piston seal 120 are also shown separately in the perspective view of Figure 15, the cross-sectional view of Figure 16, and the side view of Figure 17 with the outer housing 112 removed.

[0094] The piston member 122 and the piston seal 120 may be connected to or attached to each other, and both may be sized to fit within the compliance chamber 130 and move longitudinally between the end regions of the compliance chamber 130. In this example, both the piston member 122 and the piston seal 120 may generally have a ring shape.

[0095] The piston seal 120 may have a size and shape that seals the right / proximal portion of the compliance chamber 130 (i.e., the working volume 130A) from the left / distal portion of the compliance chamber 130. Specifically, the piston seal 120 may be in uniform contact with the inner surface of the outer housing 112 and the outer surface of the inner tube 134, creating the working volume 130A in the left / distal portion into which the expansion medium can enter.

[0096] In this example, the piston seal 120 is a cup seal having a channel 120A or a cup-shaped cross-section (e.g., a "V" or "C" cross-section) (e.g., an annular channel) extending around it in the leftward / distal direction. The cup shape may exhibit a dynamic effect in which the V or C shape expands as the pressure increases. In other words, higher pressures bias the seal more. This may be important because the housing components may be injection-molded and therefore may have drafts along their length, resulting in the annular gap increasing in size from the base to the end. In a typical seal such as an O-ring, a considerable amount of compression can occur on the ring at the base, resulting in the ring still being in contact with the inner and outer surfaces at the point of maximum movement. In some cases, depending on manufacturing tolerances, such excessive compression may be undesirable. Alternatively, the piston seal 120 may have a solid cross-sectional shape such as a square, rectangular, circular, round, triangular, or similar shape. In another alternative example, the piston seal 120 may be an "X-ring" having an generally "X" cross-sectional shape, where each side of the cross-section forms a "V" or "C" shaped cup. The piston seal 120 may be made of a flexible and elastic material.

[0097] The piston member 122 may generally be made of a rigid material and may generally have an annular / ring shape. In this example, the piston member 122 may include a groove 122A in which a portion of the piston seal 120 is located. The groove 122A may further include fastening features for further holding the piston seal 120, such as adhesive or mechanical anchors (e.g., barbs, lips, etc.).

[0098] The piston member 122 and the piston seal 120 can be biased in a direction that reduces the size of the working volume 130A within the compliance chamber 130. In this example, the piston member 122 and the piston seal 120 are biased toward the left / distal portion of the compliance chamber 130. In this example, a spring 126 generates the biasing force and is located between the piston member 122 and one end of the compliance chamber 130 (e.g., the right / proximal end). The spring 126 may be a helical coil spring as shown in the figure, or other types of springs, such as one or more leaf springs (e.g., transverse leaf springs), disc springs, flat springs, machined springs, or similar variations. Alternatively, an elastically compressible material, such as a compressible polymer / foam, may be used for the biasing force. In another alternative example, the piston mechanism may be a pneumatic or hydraulic piston mechanism in which gas or oil helps to provide the biasing force.

[0099] If the piston seal 120 includes a cup seal having a channel 120A, the compliance chamber 130 may include structural features that help maintain the “cup” shape when air is removed from the valve assembly 102. For example, when air is drawn in or vacuumed out from the valve assembly 102, the piston member 122 and the piston seal 120 may be pulled in the left / distal direction until all the air is removed, and thus a ridge 124 (e.g., an annular ridge having a shape that engages with the channel 120A) may be included around the left / distal end of the compliance chamber 130, allowing the channel 120A to engage with the ridge 124 and maintain its shape. This may help prevent portions of the piston seal 120 from folding or otherwise losing their shape.

[0100] In this example, the piston member 122 and the piston seal 120 move back and forth along an axis parallel to the axis of the medical device passage of the valve assembly 102, or between the left / distal position and the right / proximal position.

[0101] Figure 8 shows the piston member 122 and the piston seal 120 in a leftward / distal position, which can occur when air is drawn out of the valve assembly 102 before it is filled / inflated with the expansion medium, as described above.

[0102] Figure 5 shows the piston member 122 and the piston seal 120 located slightly to the right / proximal to the distal end of the compliance chamber 130. Although the dilator 106 is shown within the medical device passage of the valve assembly 102, this position of the piston member 122 and the piston seal 120 is more likely to occur when a very small diameter medical device is located within the medical device passage of the valve assembly 102, or when no medical device is present. Therefore, the majority of the expansion medium is located within the valve membrane chamber 140 generated by the valve membrane 128.

[0103] Figure 7 shows the piston member 122 and the piston seal 120 in a further rightward / proximal position and near the proximal end of the compliance chamber 130. When a relatively large diameter medical device is placed in the medical device passage of the valve assembly 102, and / or when multiple medical devices are placed side by side in the medical device passage of the valve assembly 102, a portion of the expansion medium that was in the valve membrane chamber 140 generated by the valve membrane 128 is displaced into the operating volume 130A of the compliance chamber 130, moving the piston member 122 and the piston seal 120 to the rightward / distal direction against the spring 126.

[0104] Figure 9 shows an enlarged view of a portion of the valve assembly 102, which better illustrates the possible paths the expansion medium can take. The arrows indicate exemplary directions of the expansion medium in several situations, but it should be understood that during normal operation, the expansion medium can move back and forth in any direction along this portion of the path.

[0105] Figure 9 also better illustrates the valve diaphragm chamber 140. In this example, the valve diaphragm chamber 140 may consist of the valve diaphragm 128, a spacer 136, and the inner tube 134. The spacer 136 may also include a generally tubular shape having a plurality of openings 136A that allow the expansion medium to pass through, as can also be seen in Figure 14. In some examples, the spacer 136 may have an open or "C" cross-sectional shape, and in other examples, the spacer 136 may have a closed or "O" cross-sectional shape. As seen in Figure 9, the spacer 136 may help to create a longitudinal passage that opens into a region 142, together with the inner tube 134. The region 142 also opens into the operating volume 130A of the compliance chamber 130.

[0106] In this regard, the expansion medium may be filled or injected into the valve assembly 102 via the expansion tube 110A, allowing the expansion medium to pass into region 142 and then into the working volume 130A of the valve diaphragm chamber 140 and the compliance chamber 130. When the fluid is displaced from the valve diaphragm chamber 140, it enters the working volume 130A of the compliance chamber 130 and pushes back the piston member 122 and the piston seal 120 to increase the size of the working volume 130A as needed against the biasing force of the spring 126.

[0107] It may be desirable for a physician using the introducer system 100 to understand that sufficient expansion medium has been introduced into the valve assembly 102 to adequately close the valve mechanism (e.g., valve membrane 128) of the medical device passage. In one example, this may be achieved by including a pressure measuring mechanism that measures the amount of pressure generated in the expansion medium by the spring 126 (or other biasing mechanism).

[0108] In one example, the pressure measuring mechanism may include a partially or completely transparent outer housing 112 to indicate the position of the piston member 122 and the piston seal 120. For example, Figure 18 shows a valve assembly 102 with an outer housing 112 having a transparent portion 112A. In some examples, the entire outer housing 112 may be made of a transparent material, and in other examples, only a portion of the outer housing 112 may be made of a transparent material (e.g., a window or tubular section).

[0109] The markings 150 may also be included on or near the transparent portion 112A. These markings 150 may be positioned and / or calibrated so that the position of the piston seal 120 and / or the piston member 122 aligns with a specific pressure caused by the spring 126. In one example, the markings 150 may include a numerical scale (e.g., PSI) indicating a pressure measurement and / or non-numerical markers positioned longitudinally along the outer housing 112 (e.g., parallel to an axis extending through the medical device passage). In some examples, the markings 150 may include or exceed a range of values ​​including at least 11 PSI and 24 PSI (or their equivalents in other units). In some examples, it may be desirable to maintain the pressure of the expansion medium within a broad range of about 6.5 PSI to about 8.5 PSI. For example, about 6.5, 7.0, 7.5, 8.0, or 8.5 PSI (plus or minus about 0.5 PSI). In some cases, a pressure of approximately 7.5 PSI can provide the desired seal for the valve diaphragm 128.

[0110] Alternatively, a pressure measuring device located outside the outer housing 112 and communicating with the inside of the valve assembly 102 may also be used.

[0111] In another alternative example, the marker 150 may indicate the volume of the expansion medium within the valve assembly 102.

[0112] In another alternative, the marker 150 may not indicate a specific unit of measurement, but instead provide a desired “position” or “zone of position” where the piston member 122 and / or the piston seal 120 should be located during expansion. Such a position or zone may be calibrated to be equal to a desired pressure within the valve assembly 102.

[0113] In another alternative example, the valve assembly 102 may include an electronic pressure transducer within the outer housing 112 positioned to measure the pressure of the expansion medium. The pressure transducer may be connected to an electronic display mounted outside or separated from the outer housing 112. The electronic display may show the pressure value and / or an indication that sufficient expansion medium has been injected into the valve assembly 102.

[0114] In some cases, the dilator 106 and the introducer sheath 104 may include features that minimize the sizing transition between the dilator 106 and the distal portion of the introducer sheath 104. This can help the introducer sheath 104 to engage with the side wall of the vessel into which it is inserted. These vessel walls often contain calcified lesions that can restrict the advancement of the sheath if the exposed edge of the sheath engages with them. The edge can also engage with previously implanted devices such as stents and filters.

[0115] For example, Figure 19 shows an enlarged cross-sectional view of the dilator 106 and introducer sheath 104, while Figure 20 shows an enlarged portion of region 20 in Figure 19. As previously stated, the dilator may include a conical tip 106A whose diameter decreases distally to facilitate advancement within the patient's vascular structure. The dilator 106 may also include a region 106B whose diameter decreases proximal, followed by a short region 106C distal to region 106B whose diameter increases distally. This can create circumferential grooves, channels, or depressions. The distal portion 104A of the introducer sheath 104 may also decrease distally, so that at least the tip of the introducer sheath 104 and possibly a smaller distal portion of the distal portion 104A are generally uniform in their outer diameter with the portion 106D of the dilator 106 immediately distal to the short region 106C. In this regard, the diameter between the portion 106D and the distal end of the distal portion 104A will be approximately the same. This may allow for a more uniform outer diameter transition between the dilator 106 and the introducer sheath 104.

[0116] In some examples, the axial angle of the distal portion 104A of the introducer sheath 104 is equal to or approximately equal to the axial angle of the proximal leading region 106B of the dilator 106. In some examples, the distal portion 104A of the introducer sheath 104 may have a length of about 0.05 to 0.25 inches and an inner diameter that decreases by about 0.005 to 0.030 inches (plus or minus about 0.001 inches) from the inner diameter of the proximal lumen of the distal portion 104. In some examples, the distal portion 104A of the introducer sheath 104 may be angled radially inward by about 3.633 degrees with respect to the immediately proximal portion of the introducer sheath 104, which has a constant diameter.

[0117] In some examples, the region 106B of the dilator 106 has a length of approximately 0.251 inches, and the shorter region 106C has a length of approximately 0.014 inches (both plus or minus 0.003 inches). In some examples, the region 106B of the dilator 106 has an angle of approximately 1.6 degrees (plus or minus 1 degree), and the shorter region 106C has an angle of approximately 26 degrees (plus or minus 4 degrees), both of which are radially inward and relative to the portion 106D.

[0118] The following is an example of how to use the exemplary introducer system 100 disclosed herein. However, variations of this method and the execution of only a part of this method are also contemplated.

[0119] In general, the introducer system 100 can be prepared for use. The valve 110B of the expansion passage 110 can be opened, and air can be removed from the valve assembly 102 (for example, via a syringe). The valve 110B can then be closed.

[0120] Next, a container of expansion medium (e.g., a syringe) may be connected to the valve 110B, and the valve 110B may be opened / actuated so that the expansion medium is filled or injected into the valve assembly 102. The expansion medium passes into the working volume 130A of the compliance chamber 130 and into the valve membrane chamber 140 formed by the valve membrane 128. The injection of the expansion medium continues until a desired amount is placed in the valve assembly 102. In some examples, the operator may determine this amount of expansion medium via the markings 150 and the position of the piston member 122 and / or the piston seal 120 (or alternatively, one of the other techniques previously described). Once the desired amount of expansion medium has been injected into the valve assembly 102, the valve 110B may be closed. At this point, the medical device passage in the valve assembly 102 is in the closed position.

[0121] A saline solution or similar flushing fluid may be injected into the valve 108B of the flushing passage 108 so that the fluid can push out air bubbles in the medical device passage of the valve assembly 102 and introducer sheath 104.

[0122] Next, the dilator 106 can be advanced into the proximal opening of the medical device passage of the valve assembly 102. In some examples, the clamp assembly may be a separate component already located on the end of the proximal end 106E of the dilator 106, and thus engage with the valve assembly 102 via an interlock mechanism (e.g., a tab on the distal end of the clamp assembly that engages with a groove on the proximal surface of the valve assembly 102).

[0123] When the interlock mechanism is engaged, the axial / longitudinal position of the dilator 106 can be adjusted to align its grooves (regions 106B and 106C) with the decreasing diameter portion of the distal portion 104A, thereby creating a uniform or "seamless" transition between the two components. The clamp lever 116 at the proximal end of the valve assembly 102 has an open position and a closed position, which are operated to clamp / release the proximal end 106E of the dilator 106 to the valve assembly 102, maintaining the longitudinal positions of the dilator 106 and the introducer sheath 104 relative to each other. The clamp lever 116 can be engaged to lock the dilator 106 in its axial position.

[0124] The cone tip 106A and the distal portion 104A of the introducer sheath 104 may have a guidewire lumen positioned above a guidewire previously advanced into the patient. The cone tip 106A and the distal portion 104A of the introducer sheath 104 are advanced distally above the guidewire until the introducer sheath 104 is almost inside the patient's vascular structure. As the valve membrane 128 is in an expanded state, it presses against the outer surface of the dilator 106 and seals, substantially or almost completely preventing blood leakage and maintaining hemostasis.

[0125] The dilator 106 can be drawn proximal to the introducer sheath 104 and the valve assembly 102. When the dilator 106 is removed, the expanded valve diaphragm 128 increases in size via the pressure from the compliance chamber 130, thereby closing the medical device passage.

[0126] Finally, one or more medical devices, such as guidewires and catheters, can be advanced into the valve assembly 102, into the introducer sheath 104, and into the patient. The valve membrane 128 displaces the expansion medium into the compliance chamber 130 to accommodate the inserted medical device. A single device may be inserted into the introducer system 100, or two or more devices may be inserted side by side.

[0127] In the examples provided herein, the introducer sheath 104 and the valve assembly 102 are fixed together in a way that prevents removal. However, in other examples, the valve assembly 102 and the introducer sheath 104 may be separable.

[0128] In some cases, the inflation medium may be saline solution, water, other fluids, foam, or gel. In other cases, the inflation medium may be a gas, such as air. Typically, the use of a fluid would be more preferable because it reduces the risk of gas bubbles entering the patient's vascular structure. However, a well-sealed and / or isolated compliance chamber 130 and valve membrane chamber 140 may allow the use of a gas as the inflation medium.

[0129] Although the compliance chamber 130 is generally shown as being located within the outer housing 112, which also includes the valve diaphragm chamber 140, the compliance chamber 130 may alternatively be located within a separate housing connected to the outer housing 112 via a tube or similar structure.

[0130] Although this introducer system 100 is described for use in accessing a patient's vascular structure, other non-vascular parts of the patient's structure may also be accessed.

Claims

1. It is an introducer system, Introducer sheath, The valve assembly connected to the introducer sheath, A medical device passage defined by the introducer sheath and the valve assembly, A flexible material within the valve assembly, having an inner surface exposed along a portion of the medical device passage and an outer surface that at least partially defines the valve membrane chamber, An introducer system comprising: a compliance chamber located within the valve assembly and communicating with the valve membrane chamber, the compliance chamber further including a piston assembly located within the compliance chamber and movable between a plurality of positions for accommodating an expansion medium.

2. The introducer system according to claim 1, wherein the piston assembly includes a piston seal and a piston member connected to a biasing member, the biasing member biasing the piston member to reduce the working volume of the compliance chamber.

3. The introducer system according to claim 2, wherein the compliance chamber is arranged in an annular manner around at least a portion of the valve diaphragm chamber.

4. The introducer system according to claim 3, wherein the piston member is a ring.

5. The introducer system according to claim 2, wherein the biasing member is a spring.

6. The introducer system according to claim 5, wherein the spring is a helical coil spring, a leaf spring, a disc spring, a flat plate spring, or a machined spring.

7. The introducer system according to claim 2, wherein the biasing member is an elastically compressible material, a pneumatic piston mechanism, or a hydraulic piston mechanism.

8. The introducer system according to claim 2, wherein the piston seal is a cup seal having an annular channel.

9. The introducer system according to claim 8, wherein the compliance chamber further includes an annular ridge positioned to engage with the annular channel of the cup seal.

10. The introducer system according to claim 1, wherein the flexible material generally has a tubular shape.

11. The introducer system according to claim 10, wherein the generally tubular shape has a flexible intermediate portion and radially enlarged ends.

12. The introducer system according to claim 10, wherein the flexible material forms a plurality of longitudinal pleats extending radially outward.

13. The introducer system according to claim 10, wherein the generally tubular shape further includes a slit valve covering the lumen of the generally tubular shape.

14. The introducer system according to claim 1, further comprising a clamp connected to the valve assembly, the clamp having a closed clamp position configured to clamp the proximal portion of the dilator, and an open clamp position configured to release the proximal portion of the dilator and allow longitudinal movement of the dilator relative to the introducer sheath.

15. Furthermore, the introducer system according to claim 1 further comprises a pressure measuring device.

16. The introducer system according to claim 2, wherein the valve assembly further includes a valve housing, at least a portion of which is transparent, and further includes a label indicating a pressure value of the expansion medium within the valve assembly.

17. The introducer system according to claim 16, wherein the piston member, the piston seal, or both are configured to align with the indicator to indicate the pressure value of the expansion medium in the valve assembly.

18. The introducer system according to claim 15, wherein the pressure measuring device is an electronic pressure transducer and an electronic display electrically connected to the pressure transducer.

19. The introducer system according to claim 1, wherein the compliance chamber further comprises a plurality of compliance chambers.

20. The introducer system according to claim 19, wherein the plurality of compliance chambers are arranged in a ring around the medical device passage.

21. It is an introducer system, Introducer sheath, The valve assembly connected to the introducer sheath, A medical device passage defined by the introducer sheath and the valve assembly, A valve member having an expansion configuration that seals the medical device passage within the valve assembly, An introducer system comprising a piston assembly located within the valve assembly and communicating with the valve member.

22. The introducer system according to claim 21, wherein the piston assembly is arranged in an annular manner around the medical device passage.

23. It is an introducer system, A valve assembly connected to an introducer sheath, A medical device passage defined by the valve assembly, A valve member having an expansion configuration that seals the medical device passage within the valve assembly, An introducer system comprising a piston assembly located within the valve assembly and communicating with the valve member.

24. The introducer system according to claim 23, further comprising an introducer sheath connected to the valve assembly and further defining the medical device passage.

25. It is an introducer system, Introducer sheath, The valve assembly connected to the introducer sheath, A medical device passage defined by the introducer sheath and the valve assembly, An introducer system comprising a pressure measuring mechanism configured to transmit pressure within the valve assembly.

26. The introducer system according to claim 25, wherein the pressure measuring mechanism includes a transparent portion of the housing of the valve assembly, and the pressure measuring mechanism is configured to measure the expansion medium within the valve assembly.

27. The introducer system according to claim 26, further comprising a marker located on the housing of the valve assembly, wherein the marker is configured to indicate the pressure of the expansion medium in the valve assembly based on the position of the components in the compliance chamber of the valve assembly.

28. The introducer system according to claim 25, wherein the pressure measuring mechanism includes an electronic pressure transducer connected to an electronic display configured to display a pressure value measured from the electronic pressure transducer.

29. A method for using the introducer system, To provide an introducer system comprising an introducer sheath and a valve assembly, wherein the introducer sheath and the valve assembly define a medical device passage, The valve assembly is filled with the expansion medium until the flexible material expands and enlarges into the medical device passage, thereby closing the medical device passage. Placing the medical device within the medical device passage, A method comprising housing an expanded medium, displaced by the movement of the flexible material by the medical device, through a compliance chamber in the valve assembly, wherein the compliance chamber includes a piston assembly.

30. It is an introducer system, Introducer sheath, The valve assembly connected to the introducer sheath, A medical device passage defined by the introducer sheath and the valve assembly, Equipped with a dilator, An introducer system comprising a dilator including a distal region having an annular channel, and an introducer sheath including a distal end whose diameter decreases distally so as to fit within the annular channel of the dilator, thereby minimizing the transition between the outer surface of the dilator and the outer surface of the introducer sheath.

31. It is an introducer system, Introducer sheath, The valve assembly connected to the introducer sheath, A medical device passage defined by the introducer sheath and the valve assembly, A dilator comprising a distal region having an annular channel, wherein the introducer sheath includes a distal end whose diameter decreases distally so as to fit within the annular channel of the dilator, and minimizes the transition between the outer surface of the dilator and the outer surface of the introducer sheath, An introducer system comprising: a clamp assembly having an open state that allows longitudinal movement of the dilator relative to the valve assembly and the introducer sheath, and a clamped state that prevents longitudinal movement of the dilator relative to the valve assembly and the introducer sheath.

32. The introducer system according to claim 31, wherein the clamp assembly can be attached to the proximal portion of the valve assembly via an interlock mechanism.

33. A method for using the introducer system, To provide an introducer system comprising an introducer sheath and a valve assembly, wherein the introducer sheath and the valve assembly define a medical device passage, Inserting the dilator into the valve assembly and introducer sheath, The longitudinal position of the dilator is adjusted so that the channel on the distal portion of the dilator is aligned with the distal end of the introducer sheath, A method comprising clamping the proximal portion of the dilator to the valve assembly to prevent longitudinal movement of the dilator relative to the valve assembly and the introducer sheath.

34. The method according to claim 33, wherein the step of inserting the dilator into the valve assembly further includes connecting an interlock assembly of a clamp assembly located on the proximal portion of the dilator to the valve assembly.

35. It is an introducer system, Introducer sheath, The valve assembly connected to the introducer sheath, A medical device passage defined by the introducer sheath and the valve assembly, A dilator comprising a distal region having an annular channel, wherein the introducer sheath includes a distal end whose diameter decreases distally so as to fit within the annular channel of the dilator, and minimizes the transition between the outer surface of the dilator and the outer surface of the introducer sheath, An introducer system comprising: a sheath moving assembly, which includes an actuator for moving the introducer sheath longitudinally relative to the valve assembly and the dilator, and which allows a user to align the annular channel with the distal end of the introducer sheath.

36. The introducer system according to claim 35, wherein the actuator includes a thumbwheel, a slider, or a tubular actuator.

37. A method for using the introducer system, To provide an introducer system comprising an introducer sheath and a valve assembly, wherein the introducer sheath and the valve assembly define a medical device passage, Inserting the dilator into the valve assembly and introducer sheath, A method comprising adjusting the longitudinal position of the introducer sheath to align a channel on the distal portion of the dilator with the distal end of the introducer sheath.

38. The method according to claim 37, wherein the step of inserting the dilator into the valve assembly further includes connecting the dilator interlock assembly on the proximal portion of the dilator to the valve assembly.

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